CILOXAN EYE DROPS

Active substance: CIPROFLOXACIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is known as the above name but will be referred to as Ciloxan throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet
1. What Ciloxan is and what it is used for
2. Before you use Ciloxan
3. How to use Ciloxan

4. Possible side effects
5. How to store Ciloxan
6. Further information

1. WHAT CILOXAN IS AND WHAT IT IS USED FOR
Ciloxan belongs to a group of medicines known as quinolone antibiotics.
It is used for the treatment of corneal ulcers and some other bacterial infections of the eye(s).
2. BEFORE YOU USE CILOXAN
Do not use Ciloxan...
• If you are allergic (hypersensitive) to ciprofloxacin or any other quinolone antibiotic or to any of
the other ingredients listed in section 6.
Ask your doctor for advice.

DATE:

WARNING!

Take special care...
• Only use Ciloxin in your eyes.
• Only use Ciloxin in children younger than 1 year if prescribed by your doctor.
• As with any antibiotic, use of Ciloxan for a long time may lead to other infections.
If your symptoms get worse or suddenly return tell your doctor. You may become more susceptible
to other infections with the use of this medicine, especially after prolonged use.
• If you notice the first sign of a skin rash or any other allergic reaction, including hives, itching,
breathing problems stop treatment and immediately contact your doctor. If you have a serious
allergic reaction then you may need emergency treatment.
• If you feel pain, swelling or inflammation while or shortly after taking this medicine, stop treatment
and contact your doctor.
• If you are elderly or if you are taking medicines called ‘corticosteroids’ used to treat conditions such
as pain and inflammation, asthma or skin problems then you have a higher risk of getting tendon
problems during treatment with Ciloxan. If you experience any inflammation or inflammatory
condition, stop treatment and immediately consult your doctor.
Pregnancy and breast-feeding
If you are pregnant or might get pregnant, or if you are breast-feeding a baby, talk to your doctor before
you use Ciloxan.

28/06/13
DATE OF PROOF:

If you are using more than one type of eye medicine, the medicines must be used at least 5 minutes apart.
Eye ointments should be used last.
Important information if you wear Contact Lenses
There is a preservative in Ciloxan (benzalkonium chloride) that may cause eye irritation and can discolour soft
contact lenses.
Do not wear contact lenses (hard or soft) during treatment with Ciloxan.
3. HOW TO USE CILOXAN
The usual dose
This will depend on whether you are being treated for corneal ulcers or for some other bacterial infection
in your eye.

6464/2313A

DT
ARTWORKER:

DATE:

Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.

CODE:

05-0440

CUSTOMER: Waymade
PRODUCT: Ciloxan eye drops

PRE-PRESS NO.:

Q.A.
APPROVED:

Driving and using machines
If your sight is temporarily blurred or affected in any way following use of Ciloxan you should not drive or
operate machinery until your vision is clear again.

Corneal Ulcers
Dosing is continued during the night time.
Day 1 - 2 drops every 15 minutes for the first 6 hours and then 2 drops every 30 minutes.
Day 2 - 2 drops every hour.
Day 3 to Day 14 - 2 drops every 4 hours.
Your doctor will tell you if treatment needs to be continued for longer than 14 days.
Other bacterial infections
1 or 2 drops 4 times a day. For severe infections the dose for the first 2 days may be increased to 1 or 2
drops every 2 hours, while you are awake.
It is important that you continue to use Ciloxan for the full treatment period as advised by your doctor even
if your symptoms improve. If you stop using this medicine too early, your symptoms may re-occur.
You should not use Ciloxan for more than 21 days, unless your doctor says otherwise.
Remove the loose collar from the cap when the bottle is first opened.
Always use Ciloxan exactly as your doctor has told you. You should check with your doctor or pharmacist
if you are not sure.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Notes:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 28/06/13

Leaflet Flat Size = 148 x 317
March 2013

27mm

CILOXAN® EYE DROPS
(ciprofloxacin hydrochloride)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000A

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

1

• Do not touch your eye or eyelid, surrounding areas or other surfaces with
the dropper. It could infect the drops.
• Gently press on the base of the bottle to release one drop at a time
(picture 2).
• Do not squeeze the bottle, only a gentle press on the bottom is needed.
• If you use drops in both eyes, repeat the steps for your other eye.
Put the bottle cap firmly back on immediately after use.

2

• If a drop misses your eye, try again.
• If you forget to use Ciloxan, do not worry, just use it when it is next due. Do not take a double dose to
make up.
• If you use more Ciloxan than you should it can be washed out of your eye with lukewarm water.
• If this medicine is accidentally swallowed, it is not likely to cause any serious problems, but contact
your doctor.
If you have any further questions on the use of Ciloxan, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ciloxan can cause side effects, although not everybody gets them.

WARNING!

• You may experience some or all of the following effects in your eye(s):

Uncommon (1 to 10 users in 1,000): Damage to or staining of the eye surface (cornea), sensitivity to light,
blurred vision, swelling of the eye or eyelid, pain, dry eye, itchiness, abnormal sensation, eye discharge,
eyelid crusting, eyelids scales, eyelid redness, poor vision, watery eyes, red eyes
Rare (1 to 10 users in 10,000): Damage of the eye, inflammation, disorder of the eye surface (cornea),
double vision, decreased eye sensation, tired eyes

• You may also experience effects in other areas of your body including:
Common: Bad taste.
Uncommon: Headache, nausea.
Rare: Hypersensitivity, dizziness, ear pain, stye, inflammation inside the nose, nasal sinus discharge,
diarrhoea, abdominal pain, skin inflammation, drug intolerance, abnormal laboratory tests.
If any of the side effects get serious, or you notice any side effects not listed in this leaflet, tell your
doctor or pharmacist.
If you experience an allergic reaction, stop using Ciloxan and tell your doctor.

28/06/13
DATE OF PROOF:

6. FURTHER INFORMATION
Your medicine is called Ciloxan eye drops. Each millilitre of solution contains 3.5mg of ciprofloxacin
hydrochloride (equivalent to 3.0mg of ciprofloxacin) in a clear, colourless solution. It also contains 0.06mg
of benzalkonium chloride in each ml of solution as a preservative.
6464/2313A

DT
ARTWORKER:

DATE:

5. HOW TO STORE CILOXAN
• Ciloxan eye drops should not be stored above 25°C. The bottle should be discarded one month after first
opening.
• Do not use after the expiry date printed on the bottle or carton label. The expiry date refers to the last day
of that month.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop using the drops, please take them back to the pharmacist for safe disposal.
Only keep the medicine if your doctor tells you to.
• If the drops become discoloured or show any other signs of deterioration, you should seek the advice of
your pharmacist before using them.
• Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
• Do not pass this medicine on to others. It may harm them, even if their symptoms are the same as yours

CODE:

05-0440

CUSTOMER: Waymade
PRODUCT: Ciloxan eye drops

PRE-PRESS NO.:

Q.A.
APPROVED:

If you notice white particles in your eyes, continue to use Ciloxan but tell your doctor immediately.

Ciloxan eye drops also contain the following:
sodium acetate, acetic acid, mannitol, disodium edetate and purified water. Hydrochloric acid and/or sodium
hydroxide may be included in very small quantities to adjust the acidity and alkalinity of the product to ensure
comfort of the product in the eye.
Ciloxan eye drops are available as plastic dropper bottles of 5mls of solution.
POM

PL No: 6464/2313

This product is manufactured by Alcon Cusi SA, c/ Camil Fabra, 58, 08320 El Masnou-Barcelona, Spain and
is procured from within the EU and repackaged by the Product Licence holder who is:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 28.06.2013
Ciloxan is a registered trademark of Alcon.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

Common (1 to 10 users in 100): White deposits on the eye surface (cornea), discomfort (stinging or burning,
gritty feeling in the eye, irritation), redness.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

PROOF HISTORY:
v.1 - waymade - 28/06/13

Leaflet Flat Size = 148 x 317
March 2013

27mm

How to use
• Wash your hands before you start.
• Twist off the bottle cap.
• Hold the bottle pointing down, between your thumb and fingers.
• Tilt your head back.
• Pull down your lower eyelid with a finger, until there is a 'pocket' between
the eyelid and your eye. The drop will go in here (picture 1).
• Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)